Canine Atopic Dermatitis lmmunotherapeutic is a ready-to-use, sterile liquid containing a caninized monoclonal antibody (mAb) against interleukin-31 (IL-31). IL-31 has been shown to induce pruritus in dogs in laboratory studies.

Canine Atopic Dermatitis lmmunotherapeutic remains in circulation for several weeks. It exerts a therapeutic effect by binding to and neutralizing soluble IL-31, thus inhibiting pruritus and reducing skin lesions. Like other naturally-occurring antibodies and antibody-antigen complexes, elimination is via normal protein degradation pathways.

SAFETY: A field safety study has demonstrated that Canine Atopic Dermatitis lmmunotherapeutic is well tolerated in dogs after subcutaneous injection. Adverse events occurred at a similar frequency between treated and placebo groups in a study of 245 canine patients presented to veterinary hospitals and diagnosed with atopic dermatitis. In this study, dogs were administered Canine Atopic Dermatitis lmmunotherapeutic (1.0-3.3 mg/kg body weight) or placebo by the subcutaneous route on Days 0 and 28. Signs of patient discomfort on administration and adverse events occurred at a similar frequency between treatment groups. In addition, there was no clinically important difference in clinical pathology changes between groups following either dose. A wide variety of concomitant medications were safely used, including parasiticides, antibiotics, antifungals, corticosteroids, vaccines, immunotherapy, antihistamines and other antipruritics, such as oclacitinib and cyclosporine.

Canine Atopic Dermatitis lmmunotherapeutic has also been demonstrated to be well-tolerated in dogs in a laboratory safety study in which 7 consecutive monthly subcutaneous injections were administered at doses of 3.3 mg/kg or 10 mg/kg body weight (12 dogs per group).

Effectiveness

Canine Atopic Dermatitis lmmunotherapeutic has a demonstrated onset of efficacy within 1 day and maintains efficacy for 1 month following a single dose in the field study.

In a study of 211 canine patients presented to veterinary hospitals and diagnosed with atopic dermatitis, a single dose of Canine Atopic Dermatitis lmmunotherapeutic (up to 2.0 mg/kg) or placebo was administered subcutaneously. The study confirmed a significant (P<0.05) increase in the frequency of treatment success compared to placebo for at least one month at a dose of 2.0 mg/kg. Treatment success measures were based on the owner assessment of pruritus (Visual Analog Scale; VAS) scores and veterinarian assessment of skin lesion scores (Canine Atopic Dermatitis Extent and Severity Index; CADESI-03).

Aseptically withdraw the full volume of the appropriate vial according to the dosage table below and administer subcutaneously.

Dog Body Weight in Pounds

Dog Body Weight in Kilograms

Presentation

10 mg (Green)

20 mg (Blue)

30 mg (Purple)

40 mg (Orange)

5.0 - 10

2.3 - 4.5

1 vial

10.1 - 20

4.6 - 9.1

1 vial

20.1 - 30

9.2 - 13.6

1 vial

30.1 - 40

13.7 - 18.1

1 vial

Dogs weighing > 40 lb (18.1 kg):

A single dose requires a combination of vials, as outlined in the table below. Prior to administration, collect the number of vials indicated under each presentation according to the dog’s body weight.

Aseptically draw the full volume from each vial into one syringe and administer subcutaneously as a single injection.

Dog Body Weight in Pounds

Dog Body Weight in Kilograms

Presentation

10 mg (Green)

20 mg (Blue)

30 mg (Purple)

40 mg (Orange)

40.1 - 50

18.2 - 22.7

1 vial +

1 vial

50.1 - 60

22.8 - 27.2

1 vial +

1 vial

60.1 - 70

27.3 - 31.7

1 vial +

1 vial

70.1 - 80

31.8 - 36.3

2 vials

80.1 - 90

36.4 - 40.8

1 vial +

2 vials

90.1 - 100

40.9 - 45.4

1 vial +

2 vials

100.1 - 110

45.5 - 49.9

1 vial +

2 vials

110.1 - 120

50.0 - 54.4

3 vials

120.1 - 130

54.5 - 59.0

1 vial +

3 vials

130.1 - 140

59.1 - 63.5

1 vial +

3 vials

140.1 - 150

63.6 - 68.0

1 vial +

3 vials

150.1 - 160

68.1 - 72.6

4 vials

160.1 - 170

72.7 - 77.1

1 vial +

4 vials

170.1 - 180

77.2 - 81.6

1 vial +

4 vials

180.1 - 190

81.7 - 86.2

1 vial +

4 vials

190.1 - 200

86.3 - 90.7

5 vials

Precautions

1. The product does not have preservative. Each vial is for single use only, and should be discarded after puncture.

This product has been shown to be efficacious in treating healthy dogs with canine atopic dermatitis.

U.S. Veterinary License No. 190

Zoetis Inc., Kalamazoo, MI 49007, USA

50006400

NAC No.: 3690364.1

ZOETIS INC.333 PORTAGE STREET, KALAMAZOO, MI, 49007

Telephone:

269-359-4414

Customer Service:

888-963-8471

Website:

www.zoetis.com

Every effort has been made to ensure the accuracy of the Canine Atopic Dermatitis Immunotherapeutic information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.